Trial Outcomes & Findings for Non-anesthesiologist-administered Propofol During the Flexible Bronchoscopy (NCT NCT02820051)

NCT ID: NCT02820051

Last Updated: 2024-12-02

Results Overview

Our primary outcome was to assess the difference in PtCO2 values during and after FB between the groups. We hypothesized that PtcO2 values are not higher in patients who received NAAP balanced sedation.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 102 participants
• Primary outcome timeframe: Change from Baseline PtcCO2 (minute 0) to PtcCO2 at minute 60
• Results posted on: 2024-12-02

Participant Flow

Between February and July 2014, we prospectively included ambulatory patients > 18 years of age with an indication for FB. Bronchoscopic procedures were performed by residents of Respiratory and Critical Care Medicine under the supervision of an attendant professor in a tertiary-referral university hospital in northern Mexico.

Participant milestones

Measure	Midazolam In the group of midazolam, the initial dose was 0.05 mg/kg. Additional doses of 2 mg of midazolam were allowed to reach a score level of 3 to 4 in the Observer´s assessment of alertness/ sedation scale. All patients received nalbuphine in a starting dose of 2 mg with additional doses of 1 mg if it was necessary. Lidocaine spray was applied to the nasal mucosa and pharynx for bronchoscope nostril insertion, and only in the pharynx for bronchoscope oral insertion. Topical lidocaine was applied using the spray-as-you-go technique, at a maximum dose of 7 mg/kg. Intervention: Transcutaneous CO2 monitor Transcutaneous CO2 monitor: Measurement and surveillance of transcutaneous CO2 pressure (PtcCO2) to determine PtcCO2 behavior for each sedation group. Midazolam: The initial dose was 0.05 mg/kg. Additional doses of 2 mg of midazolam were allowed to reach a score level of three to four in the Observer´s assessment of alertness/ sedation scale Nalbuphine: The starting dose was 2 mg	Propofol In the group of propofol, the starting dose was 0.1 mg /kg. Additional doses of 10 mg of propofol were allowed to reach a score level of 3 to 4 in the Observer´s assessment of alertness/ sedation scale. All patients received nalbuphine in a starting dose of 2 mg with additional doses of 1 mg if it was necessary. Lidocaine spray was applied to the nasal mucosa and pharynx for bronchoscope nostril insertion, and only in the pharynx for bronchoscope oral insertion. Topical lidocaine was applied using the spray-as-you-go technique, at a maximum dose of 7 mg/kg. Intervention: Transcutaneous CO2 monitor Transcutaneous CO2 monitor: Measurement and surveillance of transcutaneous CO2 pressure (PtcCO2) to determine PtcCO2 behavior for each sedation group. Propofol: The initial dose was 0.1 mg /kg. Additional doses of 10 mg of propofol were allowed to reach a score level of three to four in the Observer´s assessment of alertness/ sedation scale. Nalbuphine: The starting dose was 2 mg
Overall Study STARTED	49	53
Overall Study COMPLETED	42	49
Overall Study NOT COMPLETED	7	4

Reasons for withdrawal

Measure	Midazolam In the group of midazolam, the initial dose was 0.05 mg/kg. Additional doses of 2 mg of midazolam were allowed to reach a score level of 3 to 4 in the Observer´s assessment of alertness/ sedation scale. All patients received nalbuphine in a starting dose of 2 mg with additional doses of 1 mg if it was necessary. Lidocaine spray was applied to the nasal mucosa and pharynx for bronchoscope nostril insertion, and only in the pharynx for bronchoscope oral insertion. Topical lidocaine was applied using the spray-as-you-go technique, at a maximum dose of 7 mg/kg. Intervention: Transcutaneous CO2 monitor Transcutaneous CO2 monitor: Measurement and surveillance of transcutaneous CO2 pressure (PtcCO2) to determine PtcCO2 behavior for each sedation group. Midazolam: The initial dose was 0.05 mg/kg. Additional doses of 2 mg of midazolam were allowed to reach a score level of three to four in the Observer´s assessment of alertness/ sedation scale Nalbuphine: The starting dose was 2 mg	Propofol In the group of propofol, the starting dose was 0.1 mg /kg. Additional doses of 10 mg of propofol were allowed to reach a score level of 3 to 4 in the Observer´s assessment of alertness/ sedation scale. All patients received nalbuphine in a starting dose of 2 mg with additional doses of 1 mg if it was necessary. Lidocaine spray was applied to the nasal mucosa and pharynx for bronchoscope nostril insertion, and only in the pharynx for bronchoscope oral insertion. Topical lidocaine was applied using the spray-as-you-go technique, at a maximum dose of 7 mg/kg. Intervention: Transcutaneous CO2 monitor Transcutaneous CO2 monitor: Measurement and surveillance of transcutaneous CO2 pressure (PtcCO2) to determine PtcCO2 behavior for each sedation group. Propofol: The initial dose was 0.1 mg /kg. Additional doses of 10 mg of propofol were allowed to reach a score level of three to four in the Observer´s assessment of alertness/ sedation scale. Nalbuphine: The starting dose was 2 mg
Overall Study Lost to Follow-up	7	4

Baseline Characteristics

Eleven patients were lost to follow-up due to sensor dysfunction (seven in the midazolam group and four in the propofol group)

Baseline characteristics by cohort

Measure	Midazolam n=42 Participants In the group of midazolam, the initial dose was 0.05 mg/kg. Additional doses of 2 mg of midazolam were allowed to reach a score level of 3 to 4 in the Observer´s assessment of alertness/ sedation scale. All patients received nalbuphine in a starting dose of 2 mg with additional doses of 1 mg if it was necessary. Lidocaine spray was applied to the nasal mucosa and pharynx for bronchoscope nostril insertion, and only in the pharynx for bronchoscope oral insertion. Topical lidocaine was applied using the spray-as-you-go technique, at a maximum dose of 7 mg/kg. Intervention: Transcutaneous CO2 monitor Transcutaneous CO2 monitor: Measurement and surveillance of transcutaneous CO2 pressure (PtcCO2) to determine PtcCO2 behavior for each sedation group. Midazolam: The initial dose was 0.05 mg/kg. Additional doses of 2 mg of midazolam were allowed to reach a score level of three to four in the Observer´s assessment of alertness/ sedation scale Nalbuphine: The starting dose was 2 mg	Propofol n=49 Participants In the group of propofol, the starting dose was 0.1 mg /kg. Additional doses of 10 mg of propofol were allowed to reach a score level of 3 to 4 in the Observer´s assessment of alertness/ sedation scale. All patients received nalbuphine in a starting dose of 2 mg with additional doses of 1 mg if it was necessary. Lidocaine spray was applied to the nasal mucosa and pharynx for bronchoscope nostril insertion, and only in the pharynx for bronchoscope oral insertion. Topical lidocaine was applied using the spray-as-you-go technique, at a maximum dose of 7 mg/kg. Intervention: Transcutaneous CO2 monitor Transcutaneous CO2 monitor: Measurement and surveillance of transcutaneous CO2 pressure (PtcCO2) to determine PtcCO2 behavior for each sedation group. Propofol: The initial dose was 0.1 mg /kg. Additional doses of 10 mg of propofol were allowed to reach a score level of three to four in the Observer´s assessment of alertness/ sedation scale. Nalbuphine: The starting dose was 2 mg	Total n=91 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants • Eleven patients were lost to follow-up due to sensor dysfunction (seven in the midazolam group and four in the propofol group)	0 Participants n=7 Participants • Eleven patients were lost to follow-up due to sensor dysfunction (seven in the midazolam group and four in the propofol group)	0 Participants n=5 Participants • Eleven patients were lost to follow-up due to sensor dysfunction (seven in the midazolam group and four in the propofol group)
Age, Categorical Between 18 and 65 years	42 Participants n=5 Participants • Eleven patients were lost to follow-up due to sensor dysfunction (seven in the midazolam group and four in the propofol group)	49 Participants n=7 Participants • Eleven patients were lost to follow-up due to sensor dysfunction (seven in the midazolam group and four in the propofol group)	91 Participants n=5 Participants • Eleven patients were lost to follow-up due to sensor dysfunction (seven in the midazolam group and four in the propofol group)
Age, Categorical >=65 years	0 Participants n=5 Participants • Eleven patients were lost to follow-up due to sensor dysfunction (seven in the midazolam group and four in the propofol group)	0 Participants n=7 Participants • Eleven patients were lost to follow-up due to sensor dysfunction (seven in the midazolam group and four in the propofol group)	0 Participants n=5 Participants • Eleven patients were lost to follow-up due to sensor dysfunction (seven in the midazolam group and four in the propofol group)
Age, Continuous	51.1 years STANDARD_DEVIATION 16 • n=5 Participants • Eleven patients were lost to follow-up due to sensor dysfunction (seven in the midazolam group and four in the propofol group)	46.6 years STANDARD_DEVIATION 16.3 • n=7 Participants • Eleven patients were lost to follow-up due to sensor dysfunction (seven in the midazolam group and four in the propofol group)	48.7 years STANDARD_DEVIATION 16.2 • n=5 Participants • Eleven patients were lost to follow-up due to sensor dysfunction (seven in the midazolam group and four in the propofol group)
Sex: Female, Male Female	14 Participants n=5 Participants • Eleven patients were lost to follow-up due to sensor dysfunction (seven in the midazolam group and four in the propofol group)	16 Participants n=7 Participants • Eleven patients were lost to follow-up due to sensor dysfunction (seven in the midazolam group and four in the propofol group)	30 Participants n=5 Participants • Eleven patients were lost to follow-up due to sensor dysfunction (seven in the midazolam group and four in the propofol group)
Sex: Female, Male Male	28 Participants n=5 Participants • Eleven patients were lost to follow-up due to sensor dysfunction (seven in the midazolam group and four in the propofol group)	33 Participants n=7 Participants • Eleven patients were lost to follow-up due to sensor dysfunction (seven in the midazolam group and four in the propofol group)	61 Participants n=5 Participants • Eleven patients were lost to follow-up due to sensor dysfunction (seven in the midazolam group and four in the propofol group)
Region of Enrollment Mexico	42 participants n=5 Participants • Eleven patients were lost to follow-up due to sensor dysfunction (seven in the midazolam group and four in the propofol group)	49 participants n=7 Participants • Eleven patients were lost to follow-up due to sensor dysfunction (seven in the midazolam group and four in the propofol group)	91 participants n=5 Participants • Eleven patients were lost to follow-up due to sensor dysfunction (seven in the midazolam group and four in the propofol group)

PRIMARY outcome

Timeframe: Change from Baseline PtcCO2 (minute 0) to PtcCO2 at minute 60

Our primary outcome was to assess the difference in PtCO2 values during and after FB between the groups. We hypothesized that PtcO2 values are not higher in patients who received NAAP balanced sedation.

Outcome measures

Measure	Midazolam n=42 Participants In the group of midazolam, the initial dose was 0.05 mg/kg. Additional doses of 2 mg of midazolam were allowed to reach a score level of 3 to 4 in the Observer´s assessment of alertness/ sedation scale. All patients received nalbuphine in a starting dose of 2 mg with additional doses of 1 mg if it was necessary. Lidocaine spray was applied to the nasal mucosa and pharynx for bronchoscope nostril insertion, and only in the pharynx for bronchoscope oral insertion. Topical lidocaine was applied using the spray-as-you-go technique, at a maximum dose of 7 mg/kg. Intervention: Transcutaneous CO2 monitor Transcutaneous CO2 monitor: Measurement and surveillance of transcutaneous CO2 pressure (PtcCO2) to determine PtcCO2 behavior for each sedation group. Midazolam: The initial dose was 0.05 mg/kg. Additional doses of 2 mg of midazolam were allowed to reach a score level of three to four in the Observer´s assessment of alertness/ sedation scale Nalbuphine: The starting dose was 2 mg	Propofol n=49 Participants In the group of propofol, the starting dose was 0.1 mg /kg. Additional doses of 10 mg of propofol were allowed to reach a score level of 3 to 4 in the Observer´s assessment of alertness/ sedation scale. All patients received nalbuphine in a starting dose of 2 mg with additional doses of 1 mg if it was necessary. Lidocaine spray was applied to the nasal mucosa and pharynx for bronchoscope nostril insertion, and only in the pharynx for bronchoscope oral insertion. Topical lidocaine was applied using the spray-as-you-go technique, at a maximum dose of 7 mg/kg. Intervention: Transcutaneous CO2 monitor Transcutaneous CO2 monitor: Measurement and surveillance of transcutaneous CO2 pressure (PtcCO2) to determine PtcCO2 behavior for each sedation group. Propofol: The initial dose was 0.1 mg /kg. Additional doses of 10 mg of propofol were allowed to reach a score level of three to four in the Observer´s assessment of alertness/ sedation scale. Nalbuphine: The starting dose was 2 mg
Change in Transcutaneous CO2 Pressure	43.6 Unit of Measure "mmHg" Standard Deviation 7.5	45.6 Unit of Measure "mmHg" Standard Deviation 9.6

SECONDARY outcome

Timeframe: 30 min after ending of the bronchoscopy

The assessment of the state of residual sedation was performed with the Aldrete scale at minute 30 after complete bronchoscopy.

The Aldrete's scoring system is a commonly used scale for determining when people can be safely discharged from the post-anesthesia care unit. The Minumum value is 0 points and the maximum value is 10 pots. Scores of 9 or greater allow patients to leave Post Anaesthetic Care Unit.

Outcome measures

Measure	Midazolam n=42 Participants In the group of midazolam, the initial dose was 0.05 mg/kg. Additional doses of 2 mg of midazolam were allowed to reach a score level of 3 to 4 in the Observer´s assessment of alertness/ sedation scale. All patients received nalbuphine in a starting dose of 2 mg with additional doses of 1 mg if it was necessary. Lidocaine spray was applied to the nasal mucosa and pharynx for bronchoscope nostril insertion, and only in the pharynx for bronchoscope oral insertion. Topical lidocaine was applied using the spray-as-you-go technique, at a maximum dose of 7 mg/kg. Intervention: Transcutaneous CO2 monitor Transcutaneous CO2 monitor: Measurement and surveillance of transcutaneous CO2 pressure (PtcCO2) to determine PtcCO2 behavior for each sedation group. Midazolam: The initial dose was 0.05 mg/kg. Additional doses of 2 mg of midazolam were allowed to reach a score level of three to four in the Observer´s assessment of alertness/ sedation scale Nalbuphine: The starting dose was 2 mg	Propofol n=49 Participants In the group of propofol, the starting dose was 0.1 mg /kg. Additional doses of 10 mg of propofol were allowed to reach a score level of 3 to 4 in the Observer´s assessment of alertness/ sedation scale. All patients received nalbuphine in a starting dose of 2 mg with additional doses of 1 mg if it was necessary. Lidocaine spray was applied to the nasal mucosa and pharynx for bronchoscope nostril insertion, and only in the pharynx for bronchoscope oral insertion. Topical lidocaine was applied using the spray-as-you-go technique, at a maximum dose of 7 mg/kg. Intervention: Transcutaneous CO2 monitor Transcutaneous CO2 monitor: Measurement and surveillance of transcutaneous CO2 pressure (PtcCO2) to determine PtcCO2 behavior for each sedation group. Propofol: The initial dose was 0.1 mg /kg. Additional doses of 10 mg of propofol were allowed to reach a score level of three to four in the Observer´s assessment of alertness/ sedation scale. Nalbuphine: The starting dose was 2 mg
Residual Sedation Assessed Using the Aldrete Scale	10 score on a scale Interval 9.0 to 10.0	10 score on a scale Interval 10.0 to 10.0

SECONDARY outcome

Timeframe: at discharge from bronchoscopy suite, average 60 min from FB start

At the time of discharge from the bronchoscopy suite, satisfaction was assessed using a visual analog scale of 1 (not satisfied) to 10 (very satisfied).

Outcome measures

Measure	Midazolam n=42 Participants In the group of midazolam, the initial dose was 0.05 mg/kg. Additional doses of 2 mg of midazolam were allowed to reach a score level of 3 to 4 in the Observer´s assessment of alertness/ sedation scale. All patients received nalbuphine in a starting dose of 2 mg with additional doses of 1 mg if it was necessary. Lidocaine spray was applied to the nasal mucosa and pharynx for bronchoscope nostril insertion, and only in the pharynx for bronchoscope oral insertion. Topical lidocaine was applied using the spray-as-you-go technique, at a maximum dose of 7 mg/kg. Intervention: Transcutaneous CO2 monitor Transcutaneous CO2 monitor: Measurement and surveillance of transcutaneous CO2 pressure (PtcCO2) to determine PtcCO2 behavior for each sedation group. Midazolam: The initial dose was 0.05 mg/kg. Additional doses of 2 mg of midazolam were allowed to reach a score level of three to four in the Observer´s assessment of alertness/ sedation scale Nalbuphine: The starting dose was 2 mg	Propofol n=49 Participants In the group of propofol, the starting dose was 0.1 mg /kg. Additional doses of 10 mg of propofol were allowed to reach a score level of 3 to 4 in the Observer´s assessment of alertness/ sedation scale. All patients received nalbuphine in a starting dose of 2 mg with additional doses of 1 mg if it was necessary. Lidocaine spray was applied to the nasal mucosa and pharynx for bronchoscope nostril insertion, and only in the pharynx for bronchoscope oral insertion. Topical lidocaine was applied using the spray-as-you-go technique, at a maximum dose of 7 mg/kg. Intervention: Transcutaneous CO2 monitor Transcutaneous CO2 monitor: Measurement and surveillance of transcutaneous CO2 pressure (PtcCO2) to determine PtcCO2 behavior for each sedation group. Propofol: The initial dose was 0.1 mg /kg. Additional doses of 10 mg of propofol were allowed to reach a score level of three to four in the Observer´s assessment of alertness/ sedation scale. Nalbuphine: The starting dose was 2 mg
Patient Comfort Assessed Using a Satisfaction Questionnaire	8.41 score on a scale Standard Deviation 1.25	8.97 score on a scale Standard Deviation 0.98

Adverse Events

Midazolam

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Propofol

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Midazolam n=49 participants at risk In the group of midazolam, the initial dose was 0.05 mg/kg. Additional doses of 2 mg of midazolam were allowed to reach a score level of 3 to 4 in the Observer´s assessment of alertness/ sedation scale. All patients received nalbuphine in a starting dose of 2 mg with additional doses of 1 mg if it was necessary. Lidocaine spray was applied to the nasal mucosa and pharynx for bronchoscope nostril insertion, and only in the pharynx for bronchoscope oral insertion. Topical lidocaine was applied using the spray-as-you-go technique, at a maximum dose of 7 mg/kg. Intervention: Transcutaneous CO2 monitor Transcutaneous CO2 monitor: Measurement and surveillance of transcutaneous CO2 pressure (PtcCO2) to determine PtcCO2 behavior for each sedation group. Midazolam: The initial dose was 0.05 mg/kg. Additional doses of 2 mg of midazolam were allowed to reach a score level of three to four in the Observer´s assessment of alertness/ sedation scale. Nalbuphine: The starting dose was 2 mg	Propofol n=53 participants at risk In the group of propofol, the starting dose was 0.1 mg /kg. Additional doses of 10 mg of propofol were allowed to reach a score level of 3 to 4 in the Observer´s assessment of alertness/ sedation scale. All patients received nalbuphine in a starting dose of 2 mg with additional doses of 1 mg if it was necessary. Lidocaine spray was applied to the nasal mucosa and pharynx for bronchoscope nostril insertion, and only in the pharynx for bronchoscope oral insertion. Topical lidocaine was applied using the spray-as-you-go technique, at a maximum dose of 7 mg/kg. Intervention: Transcutaneous CO2 monitor Transcutaneous CO2 monitor: Measurement and surveillance of transcutaneous CO2 pressure (PtcCO2) to determine PtcCO2 behavior for each sedation group. Propofol: The initial dose was 0.1 mg /kg. Additional doses of 10 mg of propofol were allowed to reach a score level of three to four in the Observer´s assessment of alertness/ sedation scale. Nalbuphine: The starting dose was 2 mg
Respiratory, thoracic and mediastinal disorders Bronchospasm	16.3% 8/49 • Number of events 8 • During bronchoscopy study and at sedation recovery period (on average 60 minutes from the beginning of the procedure)	13.2% 7/53 • Number of events 7 • During bronchoscopy study and at sedation recovery period (on average 60 minutes from the beginning of the procedure)
Respiratory, thoracic and mediastinal disorders Respiratory depression	2.0% 1/49 • Number of events 1 • During bronchoscopy study and at sedation recovery period (on average 60 minutes from the beginning of the procedure)	1.9% 1/53 • Number of events 1 • During bronchoscopy study and at sedation recovery period (on average 60 minutes from the beginning of the procedure)
Blood and lymphatic system disorders Hypotension	8.2% 4/49 • Number of events 4 • During bronchoscopy study and at sedation recovery period (on average 60 minutes from the beginning of the procedure)	5.7% 3/53 • Number of events 3 • During bronchoscopy study and at sedation recovery period (on average 60 minutes from the beginning of the procedure)

Additional Information

Dr. Julio E. González-Aguirre

UANL

Phone: 82204444

Email: jeglza111@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place